510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963999Substantially Equivalent

Auto Suture* Modified Endoscopic Fascia Stapler** Device

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963999 is the FDA 510(k) clearance record for AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code OCW (Endoscopic Tissue Approximation Device). FDA's definition for product code OCW reads: "To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue". FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show one recall naming K963999.

Clearance record

Decision date
Received
(51 days to decision)
Product code
OCW Endoscopic Tissue Approximation Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code OCW

Trailing 12 months
1 clearance under product code OCW in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260